MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CLINICAL CHEMISTRY GLUCOSE

Model Number	3L82-21
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed a falsely elevated glucose result while using the clinical chemistry glucose assay.The customer provided the following data for a newborn patient on (b)(6) 2017; initial result (using a glucose meter) 2.1 mmol/l (37.84 mg/dl) a new specimen was collected from the same puncture and tested was completed for confirmation using the clinical chemistry glucose assay: 3.6 mmol/l (64.68 mg/dl) the result of 3.6 mol/l was autoverified and a result of 2.1 mmol/l was generated.The specimen was tested a third time and a result of 2.1 mmol/l was generated.There was no adverse impact to patient management reported.
Additional Manufacturer Narrative
Evaluation of the customer issue included a review of the complaint text, a search for similar complaints, and a review of labeling.Return material was not available from the customer.Tracking and trending did not identify an adverse trend for falsely elevated glucose results.Labeling was reviewed and found to be adequate.Based on the available information no product deficiency of the clinical chemistry glucose assay, ln 03l82, lot 49897uq08, was identified.

• Brand Name: CLINICAL CHEMISTRY GLUCOSE
• Common Device Name: GLUCOSE
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 6578363
• Report Number: 1628664-2017-00225
• Device Sequence Number: 905085
• Product Code: CFR
• UDI-Device Identifier: 00380740006006
• UDI-Public: (01)00380740006006(17)170831(10)49897UQ08
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2017
• Device Model Number: 3L82-21
• Device Catalogue Number: 03L82-21
• Device Lot Number: 49897UQ08
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/02/2017
• Supplement Date Received by Manufacturer: 06/16/2017
• Initial Report FDA Received Date: 05/19/2017
• Supplement Report FDA Received Date: 07/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARCHITECT C4000 ANALYZER; LN (B)(4), SN (B)(4)